Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study
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Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. Methods and analysis This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. Ethics and dissemination The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences. Original language English Article number e038346 Pages (from-to) 1-12 Number of pages 12 Journal BMJ Open Volume 10 Issue number 10 DOIs https://doi.org/10.1136/bmjopen-2020-038346 Publication status Published - 20 Oct 2020 Bibliographical noteCopyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher. Keywords limb reconstruction orthopaedic & trauma surgery plastic & reconstructive surgery rehabilitation medicine Access to Document 10.1136/bmjopen-2020-038346Licence: CC BY-NC Publisher version (open access)Final published version, 3.83 MBLicence: CC BY-NC Link to publication in Scopus Fingerprint Dive into the research topics of 'Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study'. Together they form a unique fingerprint. Amputees Medicine & Life Sciences 100% Osseointegration Medicine & Life Sciences 95% Rehabilitation Medicine & Life Sciences 59% Cohort Studies Medicine & Life Sciences 53% Ethics Medicine & Life Sciences 52% Amputation Medicine & Life Sciences 49% Prospective Studies Medicine & Life Sciences 49% Bone and Bones Medicine & Life Sciences 45% View full fingerprint Cite this APA Author BIBTEX Harvard Standard RIS Vancouver Haque, R., Al-Jawazneh, S., Hoellwarth, J., Akhtar, M. A., Doshi, K., Tan, Y. C., Lu, W. Y. R., Roberts, C., & Al Muderis, M. (2020). Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study. BMJ Open, 10(10), 1-12. [e038346]. https://doi.org/10.1136/bmjopen-2020-038346 Haque, Russel ; Al-Jawazneh, Shakib ; Hoellwarth, Jason ; Akhtar, Muhammad Adeel ; Doshi, Karan ; Tan, Yao Chang ; Lu, William Yenn Ru ; Roberts, Claudia ; Al Muderis, Munjed. / Osseointegrated reconstruction and rehabilitation of transtibial amputees : the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study. In: BMJ Open. 2020 ; Vol. 10, No. 10. pp. 1-12. @article{97e165d3df5147ecbef6a07cb9bfa2be, title = "Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study", abstract = "Introduction Lower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. Methods and analysis This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. Ethics and dissemination The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences.", keywords = "limb reconstruction, orthopaedic & trauma surgery, plastic & reconstructive surgery, rehabilitation medicine", author = "Russel Haque and Shakib Al-Jawazneh and Jason Hoellwarth and Akhtar, {Muhammad Adeel} and Karan Doshi and Tan, {Yao Chang} and Lu, {William Yenn Ru} and Claudia Roberts and {Al Muderis}, Munjed", note = "Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.", year = "2020", month = oct, day = "20", doi = "10.1136/bmjopen-2020-038346", language = "English", volume = "10", pages = "1--12", journal = "BMJ Open", issn = "2044-6055", publisher = "British Medical Journal Publishing Group", number = "10", } Haque, R, Al-Jawazneh, S, Hoellwarth, J, Akhtar, MA, Doshi, K, Tan, YC, Lu, WYR, Roberts, C & Al Muderis, M 2020, 'Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study', BMJ Open, vol. 10, no. 10, e038346, pp. 1-12. https://doi.org/10.1136/bmjopen-2020-038346 Osseointegrated reconstruction and rehabilitation of transtibial amputees : the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study. / Haque, Russel; Al-Jawazneh, Shakib; Hoellwarth, Jason; Akhtar, Muhammad Adeel; Doshi, Karan; Tan, Yao Chang; Lu, William Yenn Ru; Roberts, Claudia; Al Muderis, Munjed. In: BMJ Open, Vol. 10, No. 10, e038346, 20.10.2020, p. 1-12. Research output: Contribution to journal › Article › peer-review TY - JOUR T1 - Osseointegrated reconstruction and rehabilitation of transtibial amputees T2 - the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study AU - Haque, Russel AU - Al-Jawazneh, Shakib AU - Hoellwarth, Jason AU - Akhtar, Muhammad Adeel AU - Doshi, Karan AU - Tan, Yao Chang AU - Lu, William Yenn Ru AU - Roberts, Claudia AU - Al Muderis, Munjed N1 - Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher. PY - 2020/10/20 Y1 - 2020/10/20 N2 - Introduction Lower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. Methods and analysis This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. Ethics and dissemination The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences. AB - Introduction Lower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. Methods and analysis This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. Ethics and dissemination The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences. KW - limb reconstruction KW - orthopaedic & trauma surgery KW - plastic & reconstructive surgery KW - rehabilitation medicine UR - http://www.scopus.com/inward/record.url?scp=85094219814&partnerID=8YFLogxK U2 - 10.1136/bmjopen-2020-038346 DO - 10.1136/bmjopen-2020-038346 M3 - Article C2 - 33082192 AN - SCOPUS:85094219814 VL - 10 SP - 1 EP - 12 JO - BMJ Open JF - BMJ Open SN - 2044-6055 IS - 10 M1 - e038346 ER - Haque R, Al-Jawazneh S, Hoellwarth J, Akhtar MA, Doshi K, Tan YC et al. Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study. BMJ Open. 2020 Oct 20;10(10):1-12. e038346. https://doi.org/10.1136/bmjopen-2020-038346 Powered by Pure, Scopus & Elsevier Fingerprint Engine™ © 2022 Elsevier B.V. We use cookies to help provide and enhance our service and tailor content. By continuing you agree to the use of cookies Log in to Pure About web accessibility
